Tag: US FDA

FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories
September 21, 2019 Off

FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories

By Dino Mustafić

The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.

FDA accepts AstraZeneca’s drug for multiple B-cell and other cancers.
August 2, 2017 Off

FDA accepts AstraZeneca’s drug for multiple B-cell and other cancers.

By Dino Mustafić

The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.